Phase 2
N=90
A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma
Extensive Stage Small Cell Lung Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01439568 ↗Enrolled (actual)
90
Serious AEs
41.1%
Results posted
Jul 2019
Primary outcome: Primary: Progression Free Survival (PFS) — 5.88; 5.85 Months — p=0.8072
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2510924 (Drug); Carboplatin (Drug); Etoposide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
5.88; 5.85 | 0.8072 |
| SECONDARY Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR]) |
35; 34 | — |
| SECONDARY Overall Survival (OS) |
9.72; 11.14 | — |
| SECONDARY Duration of Overall Response (DOR) |
4.83; 4.67 | — |
Summary
The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with extensive-stage disease small cell lung cancer (SCLC)
Eligibility Criteria
Inclusion Criteria
- histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma
- measurable disease as defined by the New Response Evaluation Criteria in Solid Tumors (RECIST): Revised RECIST Guideline (version 1.1)
- no prior systemic chemotherapy, immunotherapy, biological, hormonal, or investigational therapy for SCLC
- a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
- adequate organ function, including:
- hematologic: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to (≥)1.5 x 10^9/ liter (L), platelets ≥100 x 10^9/L, and hemoglobin ≥9 grams per deciliter (g/dL).
- hepatic: bilirubin less than or equal to (≤)1.5 times upper limits of normal (ULN), and alkaline phosphatase (AP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times ULN (AP, AST, and ALT ≤5 times ULN is acceptable if liver has tumor involvement
- renal: calculated creatinine clearance (CrCl) ≥45 milliliters per minute (mL/min) based on the standard Cockcroft and Gault formula
- For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation), post-menopausal (at least 12 consecutive months of amenorrhea), or compliant with a medically approved contraceptive regimen (intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
- estimated life expectancy of at least 12 weeks
- written informed consent prior to any study-specific procedures
- able and willing to learn to self-administer LY2510924, or have a caregiver who is willing to learn and able to administer LY2510924 by subcutaneous (SC) injection
Exclusion Criteria
- currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- prior treatment with carboplatin/etoposide or LY2510924
- any concurrent administration of any other antitumor therapy
- diagnosis of non-small cell lung cancer (NSCLC) or mixed NSCLC and small cell lung cancer (SCLC)
- no prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Participants with a history of low grade (Gleason score ≤6) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry
- serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the study requirements
- active or ongoing infection during screening requiring the use of systemic antibiotics
- serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease as defined by the New York Heart Association Class III or IV
- clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously- treated central nervous system (CNS) metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug.
- known or suspected allergy to any agent given in association with this trial
- pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01439568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.